ISSN 1977-0677 |
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Official Journal of the European Union |
L 184 |
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English edition |
Legislation |
Volume 60 |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/1 |
COMMISSION REGULATION (EU) 2017/1270
of 14 July 2017
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of potassium carbonate (E 501) on peeled, cut and shredded fruit and vegetables
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,
Whereas:
(1) |
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
(2) |
The Union list of food additives may be updated in accordance with the common procedure referrred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2) either on the initiative of the Commission or following an application. |
(3) |
An application for authorisation of the use of potassium carbonate (E 501) on peeled, cut and shredded fruit and vegetables was submitted on 15 October 2015 and was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
(4) |
During preparation of fresh cut fruit and vegetables, enzymatic activities may lead to a loss in quality of the products, such as browning and structural losses and to food waste. In order to avoid browning, ascorbic acid (E 300) can be used. However, ascorbic acid tends to break down cell tissue, leading to softening and discoloration of fruit and vegetables after a few days. The use of potassium carbonate (E 501) allows for a more efficient protection against browning as it functions as a stabilizer and acidity regulator and minimizes the damage to tissue caused by ascorbic acid. |
(5) |
The Scientific Committee for Food established a group ADI (Acceptable Daily Intake) level of ‘not specified’ for carbonates (3), implying that it does not represent a hazard to health when used at the levels necessary to achieve the desired technological effect. |
(6) |
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since authorisation of use of potassium carbonate (E 501) as stabilizer and acidity regulator on peeled, cut and shredded fruit and vegetables constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. |
(7) |
Therefore, it is appropriate to authorise the use of potassium carbonate (E 501) as stabilizer and acidity regulator in the food category 04.1.2 ‘Peeled, cut and shredded fruit and vegetables’ in Annex II to Regulation (EC) No 1333/2008 at quantum satis. In order to ensure that the consumer is informed about this treatment, the use of potassium carbonate (E 501) should be restricted to prepacked refrigerated unprocessed fruit and vegetables ready for consumption and prepacked unprocessed and peeled potatoes. |
(8) |
Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
(9) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 354, 31.12.2008, p. 16.
(2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(3) Report from the Scientific Committee for food, 25th series, 1990.
ANNEX
In Part E of Annex II to Regulation (EC) No 1333/2008, in food category 04.1.2 ‘Peeled, cut and shredded fruit and vegetables’, the following entry is inserted before the footnotes:
|
‘E 501 |
Potassium carbonate |
Quantum satis |
|
only prepacked refrigerated unprocessed fruit and vegetables ready for consumption and prepacked unprocessed and peeled potatoes’. |
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/3 |
COMMISSION REGULATION (EU) 2017/1271
of 14 July 2017
amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of use of silicon dioxide (E 551) in potassium nitrate (E 252)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,
Whereas:
(1) |
Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use. |
(2) |
The Union list of food additives may be updated in accordance with the common procedure referrred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2) either on the initiative of the Commission or following an application. |
(3) |
An application for authorisation of the use of silicon dioxide (E 551) as an anti-caking agent added to potassium nitrate (E 252) was submitted on 7 July 2016 and was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
(4) |
When stored, potassium nitrate (E 252) shows a strong caking tendency which hinders its use in food processing. Therefore, an anti-caking agent is needed to ensure the flow and correct dosing of this additive. The applicant has demonstrated that the authorised anti-caking agents for potassium nitrate (E 252) are not efficient or may lead to undesired changes in the pH, disturbing food processing. Meanwhile silicon dioxide (E 551) is proven to be efficient and does not react with the food nor influence the further processing of the food. |
(5) |
The Scientific Committee for Food established a group ADI (Acceptable Daily Intake) level of ‘not specified’ for silicon dioxide (E 551) and certain silicates (i.e. sodium, potassium, calcium, and magnesium silicates) when used as anticaking agents (3). That implies that silicon dioxide (E 551) does not represent a hazard to health when used at the levels necessary to achieve the desired technological effect. The additional exposure of the consumer to silicon dioxide (E 551) when used as an anticaking agent in potassium nitrate (E 252) would remain limited. |
(6) |
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex III to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. |
(7) |
Since the authorisation of the use of silicon dioxide (E 551) in potassium nitrate (E 252) constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. |
(8) |
It is therefore appropriate to authorise the use of silicon dioxide (E 551) as an anti-caking agent in potassium nitrate (E 252). |
(9) |
Annex III to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex III to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 354, 31.12.2008, p. 16.
(2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(3) Report from the Scientific Committee for food, 25th series, 1990.
ANNEX
In Part 2 of Annex III to Regulation (EC) No 1333/2008, the following entry is inserted after the last entry for food additive E 551 Silicon dioxide:
|
‘E 551 |
Silicon dioxide |
10 000 mg/kg in the preparation |
E 252 Potassium nitrate’ |
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/5 |
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1272
of 14 July 2017
establishing budgetary ceilings for 2017 applicable to certain direct support schemes provided for in Regulation (EU) No 1307/2013 of the European Parliament and of the Council
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (1), and in particular Articles 22(1), 36(4), 42(2), 47(3), 49(2), 51(4) and 53(7) thereof,
Whereas:
(1) |
For each Member State implementing the basic payment scheme provided for in Chapter 1 of Title III of Regulation (EU) No 1307/2013, the annual national ceiling referred to in Article 22(1) of that Regulation for 2017 has to be set by the Commission by deducting from the annual national ceiling set out in Annex II to that Regulation the ceilings fixed in accordance with Articles 42, 47, 49, 51 and 53 of that Regulation. In accordance with Article 22(2) of Regulation (EU) No 1307/2013 any increases applied by Member States pursuant to that provision are to be taken into account. |
(2) |
For each Member State implementing the single area payment scheme provided for in Chapter 1 of Title III of Regulation (EU) No 1307/2013, the annual national ceiling referred to in Article 36(4) of that Regulation for 2017 has to be set by the Commission by deducting from the annual national ceiling set out in Annex II to that Regulation the ceilings fixed in accordance with Articles 42, 47, 49, 51 and 53 of that Regulation. |
(3) |
For each Member State granting the redistributive payment provided for in Chapter 2 of Title III of Regulation (EU) No 1307/2013, the annual national ceiling referred to in Article 42(2) of that Regulation for 2017 has to be set by the Commission on the basis of the percentage notified by those Member States pursuant to Article 42(1) of that Regulation. |
(4) |
In relation to the payment for agricultural practices beneficial for the climate and the environment provided for in Chapter 3 of Title III of Regulation (EU) No 1307/2013 in 2017, the annual national ceilings referred to in Article 47(3) of that Regulation for 2017 have to be calculated in accordance with Article 47(1) of that Regulation and amounting to 30 % of the national ceiling of the relevant Member State as set out in Annex II to that Regulation. |
(5) |
For Member States granting the payment for areas with natural constraints provided for in Chapter 4 of Title III of Regulation (EU) No 1307/2013, the annual national ceilings referred to in Article 49(2) of that Regulation for 2017 have to be set by the Commission on the basis of the percentage notified by the relevant Member States pursuant to Article 49(1) of that Regulation. |
(6) |
In relation to the payment for young farmers provided for in Chapter 5 of Title III of Regulation (EU) No 1307/2013, the annual national ceilings referred to in Article 51(4) of that Regulation for 2017 have to be set by the Commission on the basis of the percentage notified by Member States pursuant to Article 51(1) of that Regulation and have not to be higher than 2 % of the annual ceiling set out in Annex II. |
(7) |
Where the total amount of the payment for young farmers applied for in 2017 in a Member State exceeds the ceiling set pursuant to Article 51(4) of Regulation (EU) No 1307/2013 for that Member State, the difference has to be financed by the Member State in accordance with Article 51(2) of that Regulation whilst respecting the maximum amount laid down in Article 51(1) of that Regulation. For the sake of clarity, it is appropriate to set this maximum amount for each Member State. |
(8) |
For each Member State granting voluntary coupled support provided for in Chapter 1 of Title IV of Regulation (EU) No 1307/2013 in 2017, the Commission has to set the annual national ceilings referred to in Article 53(7) of that Regulation for 2017 on the basis of the percentage notified by the relevant Member State pursuant to Article 54(1) of that Regulation. |
(9) |
Concerning the year 2017, the implementation of direct support schemes provided for in Regulation (EU) No 1307/2013 started on 1 January 2017. For the sake of consistency between the applicability of that Regulation for the claim year 2017 and the applicability of the corresponding budgetary ceilings, this Regulation should apply from the same date. |
(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee for Direct Payments, |
HAS ADOPTED THIS REGULATION:
Article 1
1. The annual national ceilings for 2017 for the basic payment scheme referred to in Article 22(1) of Regulation (EU) No 1307/2013 are set out in point I of the Annex to this Regulation.
2. The annual national ceilings for 2017 for the single area payment scheme referred to in Article 36(4) of Regulation (EU) No 1307/2013 are set out in point II of the Annex to this Regulation.
3. The annual national ceilings for 2017 for the redistributive payment referred to in Article 42(2) of Regulation (EU) No 1307/2013 are set out in point III of the Annex to this Regulation.
4. The annual national ceilings for 2017 for the payment for agricultural practices beneficial for the climate and the environment referred to in Article 47(3) of Regulation (EU) No 1307/2013 are set out in point IV of the Annex to this Regulation.
5. The annual national ceilings for 2017 for the payment for areas with natural constraints referred to in Article 49(2) of Regulation (EU) No 1307/2013 are set out in point V of the Annex to this Regulation.
6. The annual national ceilings for 2017 for the payment for young farmers referred to in Article 51(4) of Regulation (EU) No 1307/2013 are set out in point VI of the Annex to this Regulation.
7. The maximum amounts for 2017 for the payment for young farmers referred to in Article 51(1) of Regulation (EU) No 1307/2013 are set out in point VII of the Annex to this Regulation.
8. The annual national ceilings for 2017 for voluntary coupled support referred to in Article 53(7) of Regulation (EU) No 1307/2013 are set out in point VIII of the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2017.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX
I. Annual national ceilings for the basic payment scheme referred to in Article 22(1) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Belgium |
222 198 |
Denmark |
553 021 |
Germany |
3 022 776 |
Ireland |
826 181 |
Greece |
1 129 245 |
Spain |
2 826 613 |
France |
3 185 167 |
Croatia |
108 746 |
Italy |
2 245 528 |
Luxembourg |
22 779 |
Malta |
648 |
Netherlands |
504 278 |
Austria |
470 393 |
Portugal |
274 189 |
Slovenia |
73 619 |
Finland |
262 269 |
Sweden |
401 863 |
United Kingdom |
2 112 701 |
II. Annual national ceilings for the single area payment scheme referred to in Article 36(4) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Bulgaria |
379 042 |
Czech Republic |
462 074 |
Estonia |
80 043 |
Cyprus |
30 396 |
Latvia |
123 537 |
Lithuania |
180 990 |
Hungary |
733 351 |
Poland |
1 559 217 |
Romania |
919 141 |
Slovakia |
252 841 |
III. Annual national ceilings for the redistributive payment referred to in Article 42(2) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Belgium |
47 460 |
Bulgaria |
55 922 |
Germany |
339 366 |
France |
723 902 |
Croatia |
24 113 |
Lithuania |
70 061 |
Poland |
289 802 |
Portugal |
16 298 |
Romania |
97 072 |
United Kingdom |
48 599 |
IV. Annual national ceilings for the payment for agricultural practices beneficial for the climate and the environment as referred to in Article 47(3) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Belgium |
150 629 |
Bulgaria |
237 968 |
Czech Republic |
252 960 |
Denmark |
250 437 |
Germany |
1 454 424 |
Estonia |
37 111 |
Ireland |
363 570 |
Greece |
562 899 |
Spain |
1 460 000 |
France |
2 171 705 |
Croatia |
72 338 |
Italy |
1 139 862 |
Cyprus |
14 900 |
Latvia |
69 129 |
Lithuania |
140 121 |
Luxembourg |
10 046 |
Hungary |
402 940 |
Malta |
1 573 |
Netherlands |
217 309 |
Austria |
207 526 |
Poland |
1 023 556 |
Portugal |
174 617 |
Romania |
540 401 |
Slovenia |
40 801 |
Slovakia |
133 391 |
Finland |
157 048 |
Sweden |
209 303 |
United Kingdom |
955 896 |
V. Annual national ceilings for payment for areas with natural constraints referred to in Article 49(2) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Denmark |
2 857 |
Slovenia |
2 149 |
VI. Annual national ceilings for the payment for young farmers referred to in Article 51(4) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Belgium |
8 367 |
Bulgaria |
1 310 |
Czech Republic |
1 686 |
Denmark |
4 341 |
Germany |
48 481 |
Estonia |
408 |
Ireland |
24 238 |
Greece |
37 527 |
Spain |
97 333 |
France |
72 390 |
Croatia |
4 823 |
Italy |
37 995 |
Cyprus |
397 |
Latvia |
3 200 |
Lithuania |
5 838 |
Luxembourg |
502 |
Hungary |
5 373 |
Malta |
21 |
Netherlands |
14 487 |
Austria |
13 835 |
Poland |
34 119 |
Portugal |
11 641 |
Romania |
18 013 |
Slovenia |
2 040 |
Slovakia |
604 |
Finland |
5 235 |
Sweden |
10 465 |
United Kingdom |
16 308 |
VII. Maximum amounts for the payment for young farmers referred to in Article 51(1) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Belgium |
10 042 |
Bulgaria |
15 865 |
Czech Republic |
16 864 |
Denmark |
16 696 |
Germany |
96 962 |
Estonia |
2 474 |
Ireland |
24 238 |
Greece |
37 527 |
Spain |
97 333 |
France |
144 780 |
Croatia |
4 823 |
Italy |
75 991 |
Cyprus |
993 |
Latvia |
4 609 |
Lithuania |
9 341 |
Luxembourg |
670 |
Hungary |
26 863 |
Malta |
105 |
Netherlands |
14 487 |
Austria |
13 835 |
Poland |
68 237 |
Portugal |
11 641 |
Romania |
36 027 |
Slovenia |
2 720 |
Slovakia |
8 893 |
Finland |
10 470 |
Sweden |
13 954 |
United Kingdom |
63 726 |
VIII. Annual national ceilings for voluntary coupled support referred to in Article 53(7) of Regulation (EU) No 1307/2013
(thousand EUR) |
|
Calendar year |
2017 |
Belgium |
83 985 |
Bulgaria |
118 984 |
Czech Republic |
126 480 |
Denmark |
24 135 |
Estonia |
6 142 |
Ireland |
3 000 |
Greece |
186 061 |
Spain |
584 919 |
France |
1 085 853 |
Croatia |
36 169 |
Italy |
455 945 |
Cyprus |
3 973 |
Latvia |
34 565 |
Lithuania |
70 060 |
Luxembourg |
160 |
Hungary |
201 470 |
Malta |
3 000 |
Netherlands |
3 500 |
Austria |
14 527 |
Poland |
505 160 |
Portugal |
117 535 |
Romania |
226 708 |
Slovenia |
17 680 |
Slovakia |
57 800 |
Finland |
102 605 |
Sweden |
90 698 |
United Kingdom |
52 815 |
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/13 |
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1273
of 14 July 2017
approving active chlorine released from sodium hypochlorite as an existing active substance for use in biocidal products of product-types 1, 2, 3, 4 and 5
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes active chlorine released from sodium hypochlorite (hereafter referred to as ‘sodium hypochlorite’). |
(2) |
Sodium hypochlorite has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in products of product-type 1, human hygiene biocidal products, product-type 2, private area and public health area disinfectants and other biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, and product-type 5, drinking water disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 1, 2, 3, 4 and 5 as defined in Annex V to Regulation (EU) No 528/2012. |
(3) |
Italy was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 17 May 2010. |
(4) |
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 14 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
(5) |
According to those opinions, biocidal products of product-types 1, 2, 3, 4 and 5 containing sodium hypochlorite may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning its use are complied with. |
(6) |
It is therefore appropriate to approve sodium hypochlorite for use in biocidal products of product-types 1, 2, 3, 4 and 5, subject to compliance with certain specifications and conditions. |
(7) |
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
Active chlorine released from sodium hypochlorite is approved as an active substance for use in biocidal products of product-types 1, 2, 3, 4 and 5, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance (1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
|||
Active chlorine released from sodium hypochlorite (hereafter referred to as ‘sodium hypochlorite’). |
IUPAC Name: Sodium hypochlorite EC No: 231-668-3 CAS No: 7681-52-9 |
Minimum purity of the releaser sodium hypochlorite: aqueous solution with an active chlorine concentration ≤ 180 g/kg (i.e. ≤ 18 % w/w). |
1 January 2019 |
31 December 2028 |
1 |
The authorisations of biocidal products are subject to the following condition: The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance. |
|||
2 |
The authorisations of biocidal products are subject to the following conditions:
|
||||||||
3 |
The authorisations of biocidal products are subject to the following conditions:
|
||||||||
4 |
The authorisations of biocidal products are subject to the following conditions:
|
||||||||
5 |
The authorisations of biocidal products are subject to the following conditions:
|
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
(2) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/17 |
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1274
of 14 July 2017
approving active chlorine released from calcium hypochlorite as an existing active substance for use in biocidal products of product-types 2, 3, 4 and 5
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes active chlorine released from calcium hypochlorite (hereafter referred to as ‘calcium hypochlorite’). |
(2) |
Calcium hypochlorite has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in products of product-type 2, private area and public health area disinfectants and other biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, and product-type 5, drinking water disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 2, 3, 4 and 5 as defined in Annex V to Regulation (EU) No 528/2012. |
(3) |
Italy was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 7 July 2010. |
(4) |
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 14 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
(5) |
According to those opinions, biocidal products of product-types 2, 3, 4 and 5 containing calcium hypochlorite may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning its use are complied with. |
(6) |
It is therefore appropriate to approve calcium hypochlorite for use in biocidal products of product-types 2, 3, 4 and 5, subject to compliance with certain specifications and conditions. |
(7) |
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
Active chlorine released from calcium hypochlorite is approved as an active substance for use in biocidal products of product-types 2, 3, 4 and 5, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance (1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
||||||||
Active chlorine released from calcium hypochlorite (hereafter referred to as ‘calcium hypochlorite’). |
IUPAC Name: Calcium hypochlorite EC No: 231-908-7 CAS No: 7778-54-3 |
Minimum purity of the releaser calcium hypochlorite: ≥ 655 g/kg (i.e. ≥ 65,5 % w/w, equivalent to an active chlorine content of 65 % w/w). |
1 January 2019 |
31 December 2028 |
2 |
The authorisations of biocidal products are subject to the following conditions:
|
||||||||
3 |
The authorisations of biocidal products are subject to the following conditions:
|
|||||||||||||
4 |
The authorisations of biocidal products are subject to the following conditions:
|
|||||||||||||
5 |
The authorisations of biocidal products are subject to the following conditions:
|
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
(2) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/21 |
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1275
of 14 July 2017
approving active chlorine released from chlorine as an existing active substance for use in biocidal products of product-types 2 and 5
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes active chlorine released from chlorine (hereafter referred to as ‘chlorine’). |
(2) |
Chlorine has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in products of product-type 2, private area and public health area disinfectants and other biocidal products, and product-type 5, drinking water disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 2 and 5 as defined in Annex V to Regulation (EU) No 528/2012. |
(3) |
Italy was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 17 May 2010. |
(4) |
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 14 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
(5) |
According to those opinions, biocidal products of product-types 2 and 5 containing chlorine may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning its use are complied with. |
(6) |
It is therefore appropriate to approve chlorine for use in biocidal products of product-types 2 and 5, subject to compliance with certain specifications and conditions. |
(7) |
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
Active chlorine released from chlorine is approved as an active substance for use in biocidal products of product-types 2 and 5, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance (1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
||||||||
Active chlorine released from chlorine (hereafter referred to as ‘chlorine’). |
IUPAC Name: Chlorine EC No: 231-959-5 CAS No: 7782-50-5 |
Minimum purity of the releaser chlorine: ≥ 995 g/kg (i.e. ≥ 99,5 % w/w) |
1 January 2019 |
31 December 2028 |
2 |
The authorisations of biocidal products are subject to the following conditions:
|
||||||||
5 |
The authorisations of biocidal products are subject to the following conditions:
|
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
(2) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/24 |
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1276
of 14 July 2017
approving peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate as an existing active substance for use in biocidal products of product-types 2, 3 and 4
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate. |
(2) |
Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in products of product-type 2, private area and public health area disinfectants and other biocidal products; product-type 3, veterinary hygiene biocidal products; and product-type 4, food and feed area disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 2, 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012. |
(3) |
Finland was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 16 January 2013. |
(4) |
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 13 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
(5) |
According to those opinions, biocidal products of product-types 2, 3 and 4 based on peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning its use are complied with. |
(6) |
It is therefore appropriate to approve peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate for use in biocidal products of product-types 2, 3 and 4, subject to compliance with certain specifications and conditions. |
(7) |
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate is approved as an active substance for use in biocidal products of product-types 2, 3 and 4, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance (1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
||||||||||||
Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate |
IUPAC Name: Peroxyethanoic acid EC No: 201-186-8 CAS No: 79-21-0 Precursors:
|
The specification for peracetic acid generated in situ is based on the precursors tetraacetylethylenediamine and sodium percarbonate. The minimum degree of purity of tetraacetylethylenediamine is 99,0 % and the minimum degree of purity of the sodium percarbonate is 85,1 % |
1 January 2019 |
31 December 2028 |
2 |
The authorisations of biocidal products are subject to the following conditions:
|
||||||||||||
3 |
The authorisations of biocidal products are subject to the following conditions:
|
|||||||||||||||||
4 |
The authorisations of biocidal products are subject to the following conditions:
|
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/27 |
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1277
of 14 July 2017
approving 2-octyl-isothiazol-3(2H)-one as an active substance for use in biocidal products of product-type 8
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 90(2) thereof,
Whereas:
(1) |
The United Kingdom received on 27 April 2010 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance 2-octyl-isothiazol-3(2H)-one in Annex I to that Directive for use in products of product-type 8, wood preservatives, as described in Annex V to that Directive, which corresponds to product-type 8 as described in Annex V to Regulation (EU) No 528/2012. |
(2) |
The United Kingdom submitted the assessment report together with its recommendations on 4 February 2016 in accordance with Article 90(2) of Regulation (EU) No 528/2012. |
(3) |
The opinion of the European Chemicals Agency was formulated on 15 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
(4) |
According to that opinion, biocidal products of product-type 8 and containing 2-octyl-isothiazol-3(2H)-one may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with. |
(5) |
It is therefore appropriate to approve 2-octyl-isothiazol-3(2H)-one for use in biocidal products of product-type 8, subject to compliance with certain specifications and conditions. |
(6) |
Since 2-octyl-isothiazol-3(2H)-one meets the criteria for classification as skin sensitiser sub-category 1A as specified in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating 2-octyl-isothiazol-3(2H)-one should be appropriately labelled when placed on the market. |
(7) |
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
2-octyl-isothiazol-3(2H)-one is approved as an active substance for use in biocidal products of product-type 8, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
(3) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance (1) |
Date of approval |
Expiry date of approval |
Product-type |
Specific conditions |
||||||
2-octyl-isothiazol-3(2H)-one |
IUPAC Name: 2-octyl-isothiazol-3(2H)-one EC No: 247-761-7 CAS No: 26530-20-1 |
960 g/kg w/w |
1 January 2018 |
31 December 2027 |
8 |
The authorisations of biocidal products are subject to the following conditions:
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating 2-octyl-isothiazol-3(2H)-one shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. |
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/30 |
COMMISSION IMPLEMENTING REGULATION (EU) 2017/1278
of 14 July 2017
approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in biocidal products of product-type 11
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes 2-methylisothiazol-3(2H)-one. |
(2) |
2-methylisothiazol-3(2H)-one has been evaluated for use in products of product-type 11, preservatives for liquid-cooling and processing systems, as described in Annex V to Regulation (EU) No 528/2012. |
(3) |
Slovenia was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 7 April 2016. |
(4) |
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 15 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
(5) |
According to that opinion, biocidal products of product-type 11 containing 2-methylisothiazol-3(2H)-one may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with. |
(6) |
It is therefore appropriate to approve 2-methylisothiazol-3(2H)-one for use in biocidal products of product-type 11, subject to compliance with certain specifications and conditions. |
(7) |
Since 2-methylisothiazol-3(2H)-one meets the criteria for classification as skin sensitiser sub-category 1A as specified in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating 2-methylisothiazol-3(2H)-one should be appropriately labelled when placed on the market. |
(8) |
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
(9) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
2-methylisothiazol-3(2H)-one is approved as an active substance for use in biocidal products of product-type 11, subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
(3) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance (1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
||||||||
2-methylisothiazol-3(2H)-one |
IUPAC Name: 2-methylisothiazol-3(2H)-one EC No: 220-239-6 CAS No: 2682-20-4 |
950 g/kg |
1 January 2019 |
31 December 2028 |
11 |
The authorisations of biocidal products are subject to the following conditions:
The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating 2-methylisothiazol-3(2H)-one shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. |
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
DIRECTIVES
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/33 |
COMMISSION IMPLEMENTING DIRECTIVE (EU) 2017/1279
of 14 July 2017
amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof,
Whereas:
(1) |
Following the recently published revision of the respective scientific denomination, Anoplophora malasiaca (Forster) is considered a synonym of Anoplophora chinensis (Thomson), already included in Section I of Part A of Annex I to Directive 2000/29/EC. Therefore, Anoplophora malasiaca (Forster) should be deleted from Section I of Part A of Annex I to Directive 2000/29/EC. |
(2) |
With a view to protecting plants, plant products and other objects, in light of increased international trade and following pest risk assessments performed and recently published by the European and Mediterranean Plant Protection Organisation, it is technically justified and consistent with the pest risks involved to add the harmful organisms Bactericera cockerelli (Sulc.), Keiferia lycopersicella (Walsingham), Saperda candida Fabricius and Thaumatotibia leucotreta (Meyrick) to Section I of Part A of Annex I to Directive 2000/29/EC. |
(3) |
It is technically justified to delete Xylella fastidiosa (Wells et al.) from Section I of Part A of Annex I to Directive 2000/29/EC and add it to Section II of that Part as this harmful organism is known to occur in the Union. |
(4) |
The presence of the harmful organism Xanthomonas campestris (all strains pathogenic to Citrus) poses an unacceptable risk to the production and the trade of plants, plant products and other objects. In addition, the strains of Xanthomonas campestris pathogenic to citrus have been reclassified. Xanthomonas citri pv. citri and Xanthomonas citri pv. aurantifolii are the causal agents of citrus canker disease. Therefore, it is scientifically justified and consistent with the pest risk involved to delete Xanthomonas campestris in Section I of Part A of Annex II to Directive 2000/29/EC and include it in Section I of Part A of Annex I to that Directive under the names Xanthomonas citri pv. aurantifolii and Xanthomonas citri pv. citri. |
(5) |
Following the revision of the respective scientific denomination, the harmful organism Guignardia citricarpa Kiely (all strains pathogenic to Citrus) has been renamed Phyllosticta citricarpa (McAlpine) Van der Aa, the causal agent of citrus black spot. It also poses an unacceptable risk to the production and the trade of plants, plant products and other objects. Therefore, it is technically justified and consistent with the pest risk involved to move that harmful organism from Section I of Part A of Annex II to Directive 2000/29/EC to Section I of Part A of Annex I to that Directive and rename it Phyllosticta citricarpa (McAlpine) Van der Aa. |
(6) |
The typographic mistakes regarding the scientific names of the harmful organisms Phyloosticta solitaria Ell. and Ev. and Popilia japonica Newman in Sections I and II, respectively, of Part A of Annex I to Directive 2000/29/EC and Aleurocantus spp. and Aonidella citrina Coquillet in Section I of Part A of Annex II to that Directive should be corrected and replaced, as applicable, by Phyllosticta solitaria Ellis & Everhart, Popillia japonica Newman, Aleurocanthus spp. and Aonidiella citrina Coquillet respectively. Similarly, typographic mistakes in the scientific denomination of Zea mays L. should also be corrected in all annexes where reference is made to that species. The typographic mistake in the scientific denomination of Amiris P. Browne in Section I of Part B of Annex V to that Directive should be corrected and replaced by Amyris P. Browne. |
(7) |
Following the recently published revision of the respective scientific denomination, Elm phlöem necrosis mycoplasm has been renamed ‘Candidatus Phytoplasma ulmi’. In addition, it is technically justified to delete that organism from Section I of Part A of Annex I to Directive 2000/29/EC (where it is listed as Elm phlöem necrosis mycoplasm) and include it in Section II of that Part as ‘Candidatus Phytoplasma ulmi’ as this harmful organism is known to occur in the Union. This is in accordance with the pest categorisation of the organism, performed by the European Food Safety Authority (EFSA) (2). The new name should also be reflected in Annex IV to Directive 2000/29/EC. |
(8) |
It is technically justified and consistent with the pest risk involved to delete the harmful organism Potato spindle tuber viroid from Section I of Part A of Annex I to Directive 2000/29/EC, since that harmful organism has spread and is established in a number of host plants within a large part of the Union. The organism is included in Section II of Part A of Annex II to that Directive in order to protect the commodities that are currently free and where its presence would pose a significant risk and causes significant losses. |
(9) |
Following the recently published revision of the respective scientific denomination, the harmful organism Xanthomonas campestris pv. pruni (Smith) Dye should be renamed Xanthomonas arboricola pv. pruni (Smith) Vauterin et al. |
(10) |
The special requirements for wood included in Section I of Part A of Annex IV to Directive 2000/29/EC should be revised in order to align them with the relevant International Standard of Phytosanitary Measures (ISPM 15) and further clarify them. In addition, the exemption of wood packing material from the specific requirements for wood of Platanus L. in that Section should be updated as it was omitted in the last amendment of that Section. |
(11) |
It is technically acceptable, on the basis of scientific and technical knowledge, to include special requirements for the introduction of certain plants, plant products and other objects into the Union due to their likelihood of hosting the harmful organisms referred to in recital (2). Therefore, the relevant plants, plant products and other objects should be listed in Part A of Annex IV to Directive 2000/29/EC. |
(12) |
In respect of the harmful organisms referred to in recitals (4), (5), and (7) it is necessary to amend the special requirements set out in Part A of Annex IV to Directive 2000/29/EC due to developments in scientific and technical knowledge and the recently published pest risk assessments carried out by EFSA. The aim of the amended requirements is to reduce the phytosanitary risk caused by the introduction into the Union of those plants, plant products and other objects originating in third countries to an acceptable level. |
(13) |
Following pest risk assessments, it is technically justified and consistent with the risks associated with the harmful organism Trioza erytreae Del Guercio to add Murraya J. Koenig ex L. to the list of host plants of that harmful organism in the relevant points in Sections I and II of Part A of Annex IV to Directive 2000/29/EC. Furthermore, Choisya Kunt should be included in the list of host plants of that harmful organism following the findings in Member States. Therefore, the special requirements for the import into and movement within the Union of the host plants in the relevant points in Sections I and II of Part A of Annex IV to Directive 2000/29/EC should be amended. |
(14) |
In addition, the plants, plant products or other objects referred to in recitals (10) to (13) should be subject to plant health inspections before being introduced into or moved within the Union. Therefore, those plants, plant products and other objects should be listed in Part A or B of Annex V to Directive 2000/29/EC. |
(15) |
The CN codes for wood set out in Annex V to Directive 2000/29/EC should be updated in order to align them with the current CN codes used in Council Regulation (EEC) No 2658/87 (3) as amended by Commission Implementing Regulation (EU) 2016/1821 (4). |
(16) |
In accordance with Commission Regulation (EC) No 690/2008 (5) certain zones have been recognised as protected zones in respect of various harmful organisms. That Regulation has recently been amended to take account of the latest developments with regard to the protected zones within the Union and the following harmful organisms: Bemisia tabaci Genn. (European populations), ‘Candidatus Phytoplasma ulmi’, Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr., Citrus tristeza virus (European strains), Curtobacterium flaccumfaciens pv. flaccumfaciens (Hedges) Col., Dryocosmus kuriphilus Yasumatsu, Erwinia amylovora (Burr.) Winsl. et al., Globodera pallida (Stone) Behrens, Globodera rostochiensis (Wollenweber) Behrens, Paysandisia archon (Burmeister), Rhynchophorus ferrugineus (Olivier), Thaumetopoea pityocampa Denis & Schiffermüller, Thaumetopoea processionea L., Tomato spotted wilt virus and Xanthomonas arboricola pv. pruni (Smith) Vauterin et al. In order to ensure that the requirements concerning protected zones with regard to the respective harmful organisms are consistent, the relevant requirements in Annexes I to V to Directive 2000/29/EC should be updated. |
(17) |
Moreover, several areas within the Union that have been recognised as protected zones with regard to certain harmful organisms no longer fulfil the requirements because those harmful organisms have become established there or the Member States concerned requested that the status as a protected zone be revoked. Those areas are the following: the region of Ribatejo e Oeste in Portugal with regard to Bemisia tabaci Genn. (European populations); the county of Odemira in Alentejo in Portugal with regard to Citrus tristeza virus (European strains); the territory of Portugal with regard to Curtobacterium flaccumfaciens pv. flaccumfaciens (Hedges) Col. and Dryocosmus kuriphilus Yasumatsu; the autonomous communities of Andalucía and Madrid and the districts (Comarcas) of Segrià, Noguera, Pla d'Urgell, Garrigues and Urgell in the province of Lleida (Comunidad autonoma de Catalunya) in Spain; the provinces of Milano and Varese (Lombardy) and the communes of Busca, Centallo and Tarantasca in the province of Cuneo (Piedmont) in Italy; the townlands of Ballinran Upper, Carrigenagh Upper, Ballinran, and Carrigenagh in County Down, and the Electoral Area of Dunmurry Cross in Belfast, County Antrim (Northern Ireland) in the United Kingdom and the entire territory of the county of Dunajská Streda in Slovakia with regard to Erwinia amylovora (Burr.) Winsl. et al.; the local authority areas of Guildford and Woking in the United Kingdom with regard to Thaumetopoea processionea L. and the territory of Finland with regard to Tomato spotted wilt virus. This should be reflected in Part B of Annexes I to IV to Directive 2000/29/EC. |
(18) |
The mistakes in the delimitation of the protected zones for Leptinotarsa decemlineata Say in Finland and Sweden in Part B of Annex I to Directive 2000/29/EC should be corrected and brought in line with Regulation (EC) No 690/2008. |
(19) |
In order to protect the production and trade of plants, plant products and other objects, it is technically justified and consistent with the pest risk involved to add the harmful organism Globodera rostochiensis (Wollenweber) Behrens to Part B of Annex I to Directive 2000/29/EC and Paysandisia archon (Burmeister), Rhynchophorus ferrugineus (Olivier), Thaumetopoea pityocampa Denis & Schiffermüller and Xanthomonas arboricola pv. pruni (Smith) Vauterin et al. to Part B of Annex II to that Directive. |
(20) |
From information provided by Portugal, it appears that the territory of the Azores is free from Globodera pallida (Stone) Behrens, Globodera rostochiensis (Wollenweber) Behrens and Rhynchophorus ferrugineus (Olivier) and that the Azores fulfil the conditions set out in point (h) of Article 2(1) of Directive 2000/29/EC for the establishment of a protected zone with respect to those harmful organisms. Part B of Annexes I, II and IV to Directive 2000/29/EC should be amended accordingly. Similarly, Part B of Annex IV and Part A of Annex V to that Directive should be amended in order to introduce requirements for the movement of certain plants, plant products and other objects into the protected zones. |
(21) |
From information provided by Ireland, Malta and the United Kingdom, it appears that the territories of those Member States are free from Paysandisia archon (Burmeister) and that those territories fulfil the conditions set out in point (h) of Article 2(1) of Directive 2000/29/EC for the establishment of a protected zone with respect to that harmful organism. Part B of Annexes II and IV to Directive 2000/29/EC should be amended accordingly. Similarly, Part B of Annex IV and Part A of Annex V to that Directive should be amended in order to introduce requirements for the movement of certain plants, plant products and other objects into the protected zones. |
(22) |
From information provided by Ireland and the United Kingdom, it appears that the territories of those Member States are free from Rhynchophorus ferrugineus (Olivier) and that those territories fulfil the conditions set out in point (h) of Article 2(1) of Directive 2000/29/EC for the establishment of a protected zone with respect to that harmful organism. Part B of Annexes II and IV to Directive 2000/29/EC should be amended accordingly. Similarly, Part B of Annex IV and Part A of Annex V to that Directive should be amended in order to introduce requirements for the movement of certain plants, plant products and other objects into the protected zones. |
(23) |
From information provided by the United Kingdom, it appears that its territory is free from Thaumetopoea pityocampa Denis & Schiffermüller and Xanthomonas arboricola pv. pruni (Smith) Vauterin et al. and that it fulfils the conditions set out in point (h) of Article 2(1) of Directive 2000/29/EC for the establishment of a protected zone with respect to those harmful organisms. Part B of Annexes II and IV to Directive 2000/29/EC should be amended accordingly. Similarly, Part B of Annex IV and Part A of Annex V to that Directive should be amended in order to introduce requirements for the movement of certain plants, plant products and other objects into the protected zones. |
(24) |
From information provided by Ireland, it appears that its territory is free from Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr. and that it fulfils the conditions set out in point (h) of Article 2(1) of Directive 2000/29/EC for the establishment of a protected zone with respect to that harmful organism. Part B of Annexes II and IV to Directive 2000/29/EC should be amended accordingly. |
(25) |
A recent pest risk analysis shows that the current requirements for the introduction and movement of certain plants, plant products and other objects into and within certain protected zones with regard to Bemisia tabaci Genn. (European populations) and Daktulosphaira vitifoliae (Fitch) are inadequate to reduce the phytosanitary risk in question to acceptable levels. Those requirements should be reformulated in Part B of Annex IV to Directive 2000/29/EC. |
(26) |
Annexes I to V to Directive 2000/29/EC should therefore be amended accordingly. |
(27) |
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annexes I to V to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 December 2017 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 January 2018.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 169, 10.7.2000, p. 1.
(2) EFSA PLH Panel (EFSA Panel on Plant Health), 2014. Scientific Opinion on the pest categorisation of Elm phloem necrosis mycoplasm. EFSA Journal 2014; 12(7):3773, 34 pp. doi:10.2903/j.efsa.2014.3773
(3) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
(4) Commission Implementing Regulation (EU) 2016/1821 of 6 October 2016 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 294, 28.10.2016, p. 1).
(5) Commission Regulation (EC) No 690/2008 of 4 July 2008 recognising protected zones exposed to particular plant health risks in the Community (OJ L 193, 22.7.2008, p. 1).
ANNEX
Annexes I to V to Directive 2000/29/EC are amended as follows:
(1) |
Annex I is amended as follows:
|
(2) |
Annex II is amended as follows:
|
(3) |
Part B of Annex III, is amended as follows:
|
(4) |
Annex IV is amended as follows:
|
(5) |
Annex V is amended as follows:
|
DECISIONS
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/63 |
POLITICAL AND SECURITY COMMITTEE DECISION (CFSP) 2017/1280
of 11 July 2017
extending the mandate of the Head of Mission of the European Union Border Assistance Mission for the Rafah Crossing Point (EU BAM Rafah) (EU BAM Rafah/1/2017)
THE POLITICAL AND SECURITY COMMITTEE,
Having regard to the Treaty on European Union, and in particular the third paragraph of Article 38 thereof,
Having regard to Council Joint Action 2005/889/CFSP of 25 November 2005 on establishing a European Union Border Assistance Mission for the Rafah Crossing Point (EU BAM Rafah) (1), and in particular Article 10(1) thereof,
Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
Whereas:
(1) |
Pursuant to Article 10(1) of Joint Action 2005/889/CFSP, the Political and Security Committee (PSC) is authorised, in accordance with Article 38 of the Treaty, to take relevant decisions for the purpose of exercising political control and strategic direction of the European Union Border Assistance Mission for the Rafah Crossing Point (EU BAM Rafah), including the decision to appoint a Head of Mission. |
(2) |
On 7 July 2015, the PSC adopted Decision EU BAM Rafah/1/2015 (2), appointing Ms Natalina CEA as Head of Mission of EU BAM Rafah from 1 July 2015 to 30 June 2016. |
(3) |
On 12 July 2016, the PSC adopted Decision EU BAM Rafah/1/2016 (3), extending the mandate of Ms Natalina CEA as Head of Mission of EU BAM Rafah for the period until 30 June 2017. |
(4) |
On 4 July 2017, the Council adopted Decision (CFSP) 2017/1193 (4), extending the mandate of EU BAM Rafah from 1 July 2017 to 30 June 2018. |
(5) |
The High Representative of the Union for Foreign Affairs and Security Policy has proposed to extend the mandate of Ms Natalina CEA as Head of Mission of EU BAM Rafah from 1 July 2017 to 30 June 2018, |
HAS ADOPTED THIS DECISION:
Article 1
The mandate of Ms Natalina CEA as Head of Mission of EU BAM Rafah is hereby extended from 1 July 2017 to 30 June 2018.
Article 2
This Decision shall enter into force on the date of its adoption.
It shall apply from 1 July 2017.
Done at Brussels, 11 July 2017.
For the Political and Security Committee
The Chairperson
W. STEVENS
(1) OJ L 327, 14.12.2005, p. 28.
(2) Political and Security Committee Decision (CFSP) 2015/1128 of 7 July 2015 on the appointment of the Head of Mission of the European Union Border Assistance Mission for the Rafah Crossing Point (EU BAM Rafah) (EU BAM Rafah/1/2015) (OJ L 184, 11.7.2015, p. 16).
(3) Political and Security Committee Decision (CFSP) 2016/1194 of 12 July 2016 extending the mandate of the Head of Mission of the European Union Border Assistance Mission for the Rafah Crossing Point (EU BAM Rafah) (EU BAM Rafah/1/2016) (OJ L 197, 22.7.2016, p. 3).
(4) Council Decision (CFSP) 2017/1193 of 4 July 2017 amending Joint Action 2005/889/CFSP on establishing a European Union Border Assistance Mission for the Rafah Crossing Point (EU BAM Rafah) (OJ L 172, 5.7.2017, p. 12).
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/65 |
COMMISSION IMPLEMENTING DECISION (EU) 2017/1281
of 13 July 2017
authorising the placing on the market of L-ergothioneine as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2017) 4844)
(Only the English text is authentic)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,
Whereas:
(1) |
On 25 July 2013, the company Tetrahedron made a request to the competent authorities of France to place synthetic L-ergothioneine (‘L-ergothioneine’) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97. The application excluded from the use infants, young children, pregnant and lactating women. |
(2) |
On 19 February 2015, the competent food assessment body of France issued its initial assessment report. In that report it came to the conclusion that L-ergothioneine meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97. |
(3) |
On 9 March 2015, the Commission forwarded the initial assessment report to the other Member States. |
(4) |
Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. |
(5) |
On 14 October 2015, the Commission consulted the European Food Safety Authority (‘EFSA’) asking it to carry out an additional assessment for L-ergothioneine as novel food ingredient in accordance with Regulation (EC) No 258/97. |
(6) |
On 26 October 2016, EFSA in its ‘Scientific Opinion on the safety of L-ergothioneine as a novel food pursuant to Regulation (EC) No 258/97’ (2) concluded that L-ergothioneine is safe for the proposed uses and use levels. |
(7) |
That opinion gives sufficient grounds to establish that L-ergothioneine in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
(8) |
Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements on food supplements. The use of L-ergothioneine should be authorised without prejudice to the provisions of that Directive. |
(9) |
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS DECISION:
Article 1
Without prejudice to Directive 2002/46/EC, L-ergothioneine as specified in Annex I may be placed on the Union market as a novel food ingredient to be used in food supplements intended for the general population, excluding infants and young children, and pregnant and lactating women, for the uses defined and at the maximum levels established in Annex II.
Article 2
The designation of L-ergothioneine authorised by this Decision on the labelling of the foodstuffs shall be ‘L-ergothioneine’.
Article 3
This Decision is addressed to Tetrahedron, 14, avenue de l'Opéra, 75001 Paris, France.
Done at Brussels, 13 July 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
(2) EFSA Journal 2016;14(11):4629.
(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
ANNEX I
SPECIFICATIONS OF L-ERGOTHIONEINE
Definition
Chemical name (IUPAC) |
(2S)-3-(2-thioxo-2,3-dihydro-1H-imidazol-4-yl)-2-(trimethylammonio)-propanoate |
Chemical formula |
C9H15N3O2S |
Molecular mass |
229,3 Da |
CAS No |
497-30-3 |
IUPAC: International Union for Pure and Applied Chemistry |
Specifications
Parameter |
Specification |
Method |
Appearance |
White powder |
Visual |
Optical rotation |
[α]D ≥ (+) 122° (c = 1, H20) (1) |
Polarimetry |
Chemical purity |
≥ 99,5 % |
HPLC [Eur. Ph. 2.2.29] |
≥ 99 % |
1H-NMR |
|
Identification |
Compliant with the structure |
1H-NMR |
C: 47,14 ± 0,4 % |
|
|
H: 6,59 ± 0,4 % |
|
|
N: 18,32 ± 0,4 % |
Elemental analysis |
|
Total residual solvents (methanol, ethyl acetate, isopropanol, ethanol) |
[Eur. Ph. 01/2008:50400] < 1 000 ppm |
Gas chromatography [Eur. Ph. 01/2008:20424] |
Loss on drying |
Internal standard < 0,5 % |
[Eur. Ph. 01/2008:20232] |
Impurities |
< 0,8 % |
HPLC/GPC or 1H-NMR |
Lead |
< 3 ppm |
ICP/AES (Pb, Cd) Atomic fluorescence (Hg) |
Cadmium |
< 1 ppm |
|
Mercury |
< 0,1 ppm |
|
Microbiological specifications (2) |
||
Total viable aerobic count (TVAC) |
≤ 1 × 103 CFU/g |
[Eur. Ph. 01/2011:50104] |
Total yeast and mould count (TYMC) |
≤ 1 × 102 CFU/g |
|
Escherichia coli |
Absent in 1 g |
|
Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy; CFU: colony-forming units. |
(1) Lit. [α]D = (+) 126,6° (c = 1, H20)
(2) Analyses conducted on each batch
(3) Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5).
ANNEX II
AUTHORISED USES OF L-ERGOTHIONEINE
Food category |
Maximum levels |
Food supplements as defined in Directive 2002/46/EC |
30 mg/day for general population (excluding pregnant and lactating women) 20 mg/day for children older than 3 years |
15.7.2017 |
EN |
Official Journal of the European Union |
L 184/69 |
COMMISSION IMPLEMENTING DECISION (EU) 2017/1282
of 14 July 2017
not approving 2-methyl-1,2-benzisothiazol-3(2H)-one as an active substance for use in biocidal products of product-type 13
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 90(2) thereof,
Whereas:
(1) |
Poland received on 26 November 2009 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance 2-methyl-1,2-benzisothiazol-3(2H)-one (EC No: n.a., CAS No 2527-66-4) in Annex I to that Directive for use in products of product-type 13, metalworking-fluid preservatives, as described in Annex V to that Directive, which corresponds to product-type 13 as described in Annex V to Regulation (EU) No 528/2012. |
(2) |
Poland submitted the assessment report together with its recommendations on 24 March 2016 in accordance with Article 90(2) of Regulation (EU) No 528/2012. |
(3) |
The opinion of the European Chemicals Agency was formulated on 16 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
(4) |
According to that opinion, biocidal products used for product-type 13 and containing 2-methyl-1,2-benzisothiazol-3(2H)-one may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012. For that product-type, the scenarios evaluated in the environmental risk assessment identified unacceptable risks. |
(5) |
It is therefore not appropriate to approve 2-methyl-1,2-benzisothiazol-3(2H)-one for use in biocidal products of product-type 13. |
(6) |
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS DECISION:
Article 1
2-methyl-1,2-benzisothiazol-3(2H)-one (EC No: n.a., CAS No 2527-66-4) is not approved as an active substance for use in biocidal products of product-type 13.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 14 July 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).